Registration Dossier

Administrative data

Endpoint:
developmental toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and there is no or no significant human exposure

Data source

Materials and methods

Results and discussion

Results (fetuses)

Fetal abnormalities

Abnormalities:
not specified

Overall developmental toxicity

Developmental effects observed:
not specified

Applicant's summary and conclusion

Conclusions:
According to column 2 of REACH Annexes on standard information requirements, the developmental toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no developmental toxicity test has been carried out and no testing is proposed at the present.
Executive summary:

According to column 2 of REACH Annexes on standard information requirements, the developmental toxicity test does not have to be performed because toxicokinetics evidences do not support the adsorption (after oral administration) and the subsequently reaching of the target tissue by the substance. Furthermore, according to column 2 of REACH Annexes on standard information requirements, the substance does not have wide dispersive use and the human exposure is limited to the workplaces where RMM can effectively limit the extent of the exposure. In light of above issues, no developmental toxicity test has been carried out and no testing is proposed at the present.